Neurostimulation Device for Treatment of Migraine Headache

NCT01630044 | Completed

• 1 other identifier: Pro00037089
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.

Conditions

Migraine Headache

Keywords

caloric vestibular stimulation

Outcome Measures

Primary Outcomes (2)

• Number of migraine headache days

  Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache.

  Length of the study, about 71 days

• Severity of each and of all headaches

  Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain).

  Length of study, 71 days

Secondary Outcomes (1)

• Total Monthly Headache Pain Score

  Length of study, about 71 days

Study Arms (1)

TNM device, active treatment

EXPERIMENTAL

This is an active-only assessment of the experimental neuromodulation device

Device: TNM device

Interventions

TNM device DEVICE

Non-invasive neurostimulator, home-use treatment for up to 43 days.

TNM device, active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
• A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
• The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
• Subject must be at least 18 years of age.

You may not qualify if:

• Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
• A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (1)

Duke Medicine / Neurology

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016.

  PMID: 27777829 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniel Laskowitz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 28, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)